DeviceClearance

Product code PLP— Gastroenterology, Urology

TULSA-PRO System

Classification name
High Intensity Ultrasound System For Prostate Tissue Ablation
Device class
Class 2
Regulation
21 CFR 876.4340
Advisory panel
Gastroenterology, Urology
Total cleared
13
First cleared
Most recent

FDA classification definition

“Prostate tissue ablation”

— U.S. Food and Drug Administration, device classification record for product code PLP under 21 CFR 876.4340, via openFDA

Market context for product code PLP

FDA has cleared 13 devices under product code PLP between 2015 and 2025, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PLP

Recent clearances under product code PLP

Data sourced from openFDA. This site is unofficial and independent of the FDA.